Heart FailureHF-RSTSNCT02077426
Heart Failure and Regional Specific Exercise Training Stimulus
A study testing Regional Specific Training (RSTS) in people with Heart Failure and Sedentary, run by Duke University at 1 site in United States.
Trial summary
The aim of this study is to determine whether heart failure patients can tolerate a four-weeks of a new exercise training regimen that targets peripheral tissues (Regional Specific Training Stimulus-RSTS) and has been show to produce significant benefits in aerobic capacity and strength in healthy subjects aged… Read more about this study
- Who is it for?
- Ages 55 to 90 years
- Conditions the study is for
- Heart Failure, Sedentary
- What is being tested?
- Regional Specific Training (RSTS)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2014to Jun 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women between the ages of 55 and 90
- Diagnosed with heart failure (NYHA class II-III)
- Receiving optimal medical therapy
- Sedentary (≤ 30 min/wk structured physical activity)
- Peak VO2 between 10 and 30 mL/kg/min.
Who cannot join
- Oxygen dependent
- Recent medications changes (within 3 months)
- Fixed-rate pacemakers
- Uncontrolled hypertension
- Type I diabetes
- Organ transplant
- Bariatric surgery
- Renal failure (stage 4 or 5)
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke Center for Living; Wallace Clinic
Durham, North Carolina, 27710
About this study
The aim of this study is to determine whether heart failure patients can tolerate a four-weeks of a new exercise training regimen that targets peripheral tissues (Regional Specific Training Stimulus-RSTS) and has been show to produce significant benefits in aerobic capacity and strength in healthy subjects aged 70+years who were at risk for losing functional independence.
- Conditions
- Heart Failure, Sedentary
- Being tested
- Regional Specific Training (RSTS)
- Keywords
- Functional Capacity, Exercise Independence, Peripheral, Strength
- Medical subject headings
- Heart Failure, Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Regional Specific Training (RSTS)Other
The RSTS protocol was designed to focus on specific peripheral muscle groups without imposing a significant cardiorespiratory strain. Each exercise involved contractions with moderate load but with an extended duration of up to six minutes. Eight specific exercises were performed to target all major muscle groups and enable the routine to be completed within 60 minutes including warm-up, rest periods and stretching between exercises, and cool down exercises.
| Study group | Role | What they receive |
|---|---|---|
| Regional Specific Training (RSTS) | Experimental | The RSTS protocol was designed to focus on specific peripheral muscle groups without imposing a significant cardiorespiratory strain. Each exercise involved contractions with moderate load but with an extended duration of up to six minutes. Eight specific exercises were performed to target all major muscle groups and enable the routine to be completed within 60 minutes including warm-up, rest periods and stretching between exercises, and cool down exercises Receives: Other: Regional Specific Training (RSTS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subject Adherence & Compliance
The number of training sessions attended and successfully completed divided by the total number of planned sessions
Measured: 4 Weeks
One Repetition Maximum (1RM)
Skeletal muscle strength assessed using a one repetition maximum (1RM) measurement obtained for the seated row, chest press, leg press and handgrip.
Measured: 4 Weeks
Senior Fitness Test
The Senior Fitness Test is a previously validated battery of 6 physical tasks of daily living used to assess strength, flexibility and endurance in order to detect and predict future limitations in functional capacity. The test is designed to evaluate physical fitness domains including upper-body strength (Arm Curl), lower-body strength (Chair Sit-Stand), upper and lower body flexibility (Back Scratch and Chair Sit and Reach), balance and coordination (8 foot Up and Go), and endurance (Six Minute Walk).
Measured: 4 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2014 (estimated)
- Study startJun 2014
- Primary completionJun 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jason D Allen, PhD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02077426
- Sponsor's protocol ID
- Pro00051711
- Acronym
- HF-RSTS
- Status last verified
- Mar 2014
- First submitted
- 28 Feb 2014
- Last updated
- 17 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Heart Failure and Regional Specific Exercise Training Stimulus
- ClinicalTrials.gov ID
- NCT02077426
- Acronym / sponsor ID
- HF-RSTS / Pro00051711
- Conditions
- Heart Failure, Sedentary
- Keywords
- Functional Capacity, Exercise Independence, Peripheral, Strength
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Jun 2016 (estimated)
- First posted
- 4 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to determine whether heart failure patients can tolerate a four-weeks of a new exercise training regimen that targets peripheral tissues (Regional Specific Training Stimulus-RSTS) and has been show to produce significant benefits in aerobic capacity and strength in healthy subjects aged 70+years who were at risk for losing functional independence.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Regional Specific Training (RSTS) | Experimental | Other: Regional Specific Training (RSTS)The RSTS protocol was designed to focus on specific peripheral muscle groups without imposing a significant cardiorespiratory strain. Each exercise involved contractions with moderate load but with an extended duration of up to six minutes. Eight specific exercises were performed to target all major muscle groups and enable the routine to be completed within 60 minutes including warm-up, rest periods and stretching between exercises, and cool down exercises |
Who may qualify
- Ages
- 55 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Men and women between the ages of 55 and 90
- Diagnosed with heart failure (NYHA class II-III)
- Receiving optimal medical therapy
- Sedentary (≤ 30 min/wk structured physical activity)
- Peak VO2 between 10 and 30 mL/kg/min.
Key exclusion criteria (8 listed)
- Oxygen dependent
- Recent medications changes (within 3 months)
- Fixed-rate pacemakers
- Uncontrolled hypertension
- Type I diabetes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Regional Specific Training (RSTS)The RSTS protocol was designed to focus on specific peripheral muscle groups without imposing a significant cardiorespiratory strain. Each exercise involved contractions with moderate load but with an extended duration of up to six minutes. Eight specific exercises were performed to target all major muscle groups and enable the routine to be completed within 60 minutes including warm-up, rest periods and stretching between exercises, and cool down exercises. | Other | Regional Specific Training (RSTS) |
Primary outcome
Subject Adherence & Compliance
Time frame: 4 Weeks
The number of training sessions attended and successfully completed divided by the total number of planned sessions
One Repetition Maximum (1RM)
Time frame: 4 Weeks
Skeletal muscle strength assessed using a one repetition maximum (1RM) measurement obtained for the seated row, chest press, leg press and handgrip.
Senior Fitness Test
Time frame: 4 Weeks
The Senior Fitness Test is a previously validated battery of 6 physical tasks of daily living used to assess strength, flexibility and endurance in order to detect and predict future limitations in functional capacity. The test is designed to evaluate physical fitness domains including upper-body strength (Arm Curl), lower-body strength (Chair Sit-Stand), upper and lower body flexibility (Back Scratch and Chair Sit and Reach), balance and coordination (8 foot Up and Go), and endurance (Six Minute Walk).
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jason D Allen, PhD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Regional Specific Training (RSTS) in people with Heart Failure and Sedentary, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 17 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subject Adherence & Compliance (time frame: 4 Weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2014.